Natasha Robbins

✨ Exciting News from TOPRA - The Organisation for Professionals in Regulatory Affairs Symposium 2024! ✨ It’s Day 1 !! Come visit Cpl Life Sciences at Stand 9 to connect and learn more about how we can support your recruitment needs in the life sciences and regulatory affairs sectors. Whether you're looking for talent or exploring new opportunities, we’re here to chat about how we can help drive your next success. See you at the TOPRA Symposium! #TOPRA2024 #LifeSciences #RegulatoryAffairs

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Q4 madness is well underway! Let’s catch up at BioProcess International in #boston Contract Pharma in #newbrunswick or CPHI in #milan The #pharma #bio contract services world has got so much happening and we’ve got lots to tell you all about so book some time with me using the link below ⬇️ in the comments.

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🚀 UKRI Launches £28.5M Human Functional Genomics Initiative 🧬 Exciting news! UK Research and Innovation (UKRI) has committed £28.5 million ($36.5 million) to launch the Human Functional Genomics Initiative (HFGI), a groundbreaking multi-institute research program focused on the role of genomic variation in human physiology and disease. 🌍💡 🔬 Key Highlights: -Funding: £7M to establish a functional genomics screening lab at the Milner Therapeutics Institute, in collaboration with AstraZeneca and the University of Cambridge. -Research Focus: Noncancerous diseases affecting the immune, cardiovascular, nervous, and respiratory systems. -Expansion Potential: The lab may expand to other disease areas in the future. Research Clusters: -The University of Edinburgh: Characterising discarded surgical tissue to study molecular mechanisms of human disease. -Imperial College London: Investigating genetic variants in rare diseases affecting amino acid and protein function. -King's College London College London: Using brain organoid models to study genetic variation in neurodevelopmental disorders. -University of Oxford: Researching musculoskeletal health and disease, identifying new therapeutic targets. 🌐 Collaboration & Innovation: £4.6M to support data coordination, networking, and collaboration among research clusters and external partners. 🗣️ Expert Insight: Jonathan Mill, HFGI Director, states: “This initiative will catalyze research into the mechanistic underpinnings of health and disease by identifying causal variants and modeling their impact in disease-relevant cell types. It will facilitate innovation and collaboration among multidisciplinary teams, and accelerate the translation of functional genomic research into tangible benefits for health and well-being.” 📈 Why Now?: Advances in gene-editing, disease-relevant cell models, whole-genome sequencing, data science, and AI make this the perfect time to launch HFGI. #Genomics #FunctionalGenomics #UKRI #MedicalResearch #Biotechnology #Innovation #CRISPR #GeneEditing #HealthResearch #Collaboration #DataScience #AI #Healthcare #ScientificResearch #HumanGenomics #DiseaseResearch

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*New openings for June*: - Senior Consultant - Global Market Access & Pricing - multiple EU & US locations - Life Sciences Consulting - Client Lead/Principal - Reputable Consulting brand - East Coast locations - some onsite work/travel 30% - Senior HEOR & Access Manager - Innovative midsized Pharma - UK - high remote flex - Senior Director - Global Market Access Consulting - multiple EU locations - LTI, BD commission, exciting team build - Senior Director - Genomics and Drug Discovery - Innovative consulting start up - Consultant - Systematic Literature Review - growing HEOR consulting firm with one of the best staff retention rates in consulting - Director (SME) Health Economic Modelling - Remote - UK, Europe, US - Top name in this field, great benefits and perks! - VP Value Communications/Market Access Consulting - London / Hybrid - Innovative growing team, people focused culture! Market Access & Pricing Consultant - Innovative growing consulting team, small specialty firm - Vice President - Life Sciences Consulting (Access, Commercial or Corporate Strategy) EU / US locations - drive sales, strategy & growth - Senior Health Economist (Consultant) - London/hybrid - Innovative firm with a great culture, work life balance, flexibility, benefits & route to Partner! - Senior RWE/HEOR Director - Mid-sized company, low staff turnover, secure and steady growth over the last 10 years! $160-200k US based - Managing Director, Commercial & Access Strategy- Growing Life Sciences Strategy house - US / UK - Principal Epidemiologist - RWE/Pharmacoepi & safety - US based - hybrid- PAS study experience, external control arms and MSc/PhD in Epidemiology essential - Senior Director - Life Sciences Strategy (PMA, Commercial & Corporate) - London or US location - award winning boutique firm with YoY growth! - Senior Director - HEOR Consulting - Copenhagen/Sweden based - innovative growing firm - Principal Consultant Health Economist - Stockholm & Copenhagen - exciting growth phase, in-demand boutique market access consultancy, good work life balance, relocation package on offer - VP/Practice Lead - Real World Evidence / Pharmacopei & Drug Safety - US or EU remote based - Director - Healthcare/Life Sciences Strategy - Midsized Consulting firm - Copenhagen - visible role, exciting growth phase, relocation support! - Senior SLR Analyst - Health Economics consulting - remote/hybrid - UK offices - Health Economic Modeller - 1-3 years experience - UK based - growing HEOR consulting firm with one of the best staff retention rates in consulting, full remote flexibility, above average employee benefits! - Statistician - Health Economics team - Reputable consultancy - would suit an experienced academic! Reach out now to confidentially discuss your career motivations and current situation in more detail - [email protected]

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For anyone in my network who did not download the AssureBio UK QP Industry Report last year, please follow the link to get your copy. I'd welcome any feedback on what you would like to see in our next report (for 2025) to ensure it's relevant to the current QP community. There have certainly been changes in the job market and dynamics of recruiting QPs, but what else would you like to learn about? [email protected] Neel Valand

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𝗧𝗵𝗲 𝗰𝗹𝗮𝘀𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗯𝗲𝘀𝘁 𝗶𝗻 𝗯𝗶𝗼𝘁𝗲𝗰𝗵 - 𝗧𝗼𝗽 𝟭𝟱! 🔥 Biotech is a highly saturated to say the least with so many coming and going within such a short period of time. This makes it very difficult to have an in depth view of who is leading the discovery curve for new therapeutics with such bold claims presented weekly. However, luckily we have our friends over at Fierce Biotech who have done the ground work for us! Check out the link below on this super exciting read on who to keep an eye on! 𝗛𝗮𝘃𝗲 𝗮 𝗹𝗼𝗼𝗸 𝘆𝗼𝘂𝗿𝘀𝗲𝗹𝗳 𝗮𝗻𝗱 𝗹𝗲𝘁 𝗺𝗲 𝗸𝗻𝗼𝘄 𝘄𝗵𝗼 𝘆𝗼𝘂 𝘄𝗼𝘂𝗹𝗱 𝗵𝗮𝘃𝗲 𝗶𝗻𝗰𝗹𝘂𝗱𝗲𝗱 𝗮𝗻𝗱 𝘁𝗮𝗴 𝘁𝗵𝗲𝗺 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁 𝘀𝗲𝗰𝘁𝗶𝗼𝗻 𝗯𝗲𝗹𝗼𝘄 Companies included are: Abdera Therapeutics Ascidian Therapeutics BigHat Biosciences Cour Pharmaceuticals Development Co., Inc. Excision BioTherapeutics Fauna Bio Gilgamesh Pharmaceuticals iECURE, inc. ILiAD Biotechnologies, LLC Kimer Med NodThera OMass Therapeutics ProFound Therapeutics Recludix Pharma Tubulis GmbH #Biotech #Therapeutics #BiotechNews https://lnkd.in/eX3g_wgP

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🚀 Exciting News in Biotech Innovation! Formation Bio Secures $372M Series D Funding 💡 Formation Bio, an AI-focused biotech company, has successfully raised $372 million in a series D funding round to further enhance its drug development capabilities. This funding, led by a16z with significant backing from Sanofi, will propel Formation Bio's mission to acquire and in-license clinical-stage assets, expanding their innovative pipeline. 🔍 What does this mean for the future of drug development? Formation Bio plans to leverage AI to streamline workflow automation in clinical trials, optimize patient recruitment, and accelerate decision-making in R&D processes. Their ambitious goal includes developing AI models to predict toxicity, tolerability, and efficacy—a transformative step forward in pharmaceutical research. 🌐 Currently, Formation Bio boasts a promising clinical pipeline, featuring candidates like gusacitinib for chronic hand eczema and ASN008 for conditions like notalgia paresthetica and atopic dermatitis itch. This funding round not only supports Formation Bio's growth but also signifies a significant investment in the future of AI-driven healthcare innovation. Stay tuned for more updates on their groundbreaking advancements! #BiotechInnovation #AIinHealthcare #SeriesDFunding #DrugDevelopment #ClinicalTrials #FormationBio #HealthTech #InnovationInPharma #Sanofi #a16z

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"Assuring a Quality Solution Each and Every Time" [email protected] AssureBio Neel Valand #contractrecruitment #permanentrecruitment #recruitmentstrategies #ir35 #pharma #biotech #qualifiedperson #qualityassurance #gmp #gdp

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Clinical Updates: #BIOSECURE Act gives drug makers until 2032 to sever ties with China. What does this mean for US Pharma? The BIOSECURE Act is a bill in the US Congress aimed at reducing reliance on Chinese biotechnology companies. It prohibits US government agencies and drug manufacturers from working with these firms, which are considered a national security risk. The latest version of the Act includes a grace period until 2032 for drugmakers to find alternative suppliers, acknowledging the challenges of an immediate switch. This could still disrupt existing supply chains and potentially lead to drug shortages or delays in research. What are tyhe possible effects? Here there is a brief summary of what this could mean for the US pharma industry: Disrupted Supply Chains: Many US drug companies rely on Chinese firms like WuXi AppTec for services like manufacturing or clinical trials. Finding new suppliers and building new partnerships will take time and resources, potentially causing delays in drug development and production. Drug Shortages: The transition period may not be smooth, leading to temporary shortages of existing medications that rely on Chinese suppliers. Increased Costs: Finding new suppliers or building in-house capabilities may be more expensive than using established Chinese firms. This could drive up drug development costs and potentially impact drug prices for consumers. Research Delays: Disruptions in ongoing research partnerships with Chinese companies could set back development timelines for new drugs and therapies. Innovation Impact: The US may lose access to some of the expertise and technologies offered by Chinese firms, potentially hindering advancements in the pharmaceutical and biotechnology sectors. https://lnkd.in/e3gvjsUd #medicalaffairs #clinicaldevelopment #medicaljobs #clinicaljobs

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If you're looking to get into Life Sciences and want to learn all about CQV (Commissioning Qualification Validation) read the short blog post below! #lifesciences #ncbiotech #pharma https://lnkd.in/eg5Rfwnh

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We've seen some more successful funding for biotech in the UK over the past week, reflecting ongoing efforts to drive innovation and address key challenges. 👉 Edinburgh-based Cytomos secured £5 million to advance its cell analysis technology, Celledonia™, aiming to enhance production and global reach. https://lnkd.in/epYPq6dk 👉 Trogenix, a University of Edinburgh spin-out, launched with £15 million in seed funding to develop highly selective, one-time tumor treatments. https://lnkd.in/euywdEWa 👉 4BIO Capital became the first UK venture fund certified by Japan's AMED, enabling support for Japanese life science ventures through non-dilutive funding. https://lnkd.in/ex6_BmpX 👉 UK Research and Innovation (UKRI) invested £5.8 million to bolster the UK's engineering biology sector, fostering innovation and economic growth. https://lnkd.in/eKvuF56r 👉 Naturbeads, based in Bath, raised £7.8 million to combat microplastic pollution, developing biodegradable cellulose beads as sustainable alternatives. https://lnkd.in/eDYVzWrb 👉 Nottingham Trent University has launched a £2.3 million accelerator project to speed up the development of rehabilitation technologies. The project will be led from NTU's Medical Technologies Innovation Facility. This initiative aims to bring world-class innovations to market faster, improving outcomes for those requiring rehabilitation. https://lnkd.in/eBgYF9qt #Biotech #LifeSciences #Innovation #Funding #Sustainability #UKBiotech

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🔬 Exciting Innovations in Mass Spectrometry! 🚀 Mass spectrometry (MS) is evolving fast, with researchers tackling bottlenecks in sensitivity, resolution, and speed. Here are a few standout breakthroughs: 1️⃣ Nanopore Ion Tech: Reducing sample loss by directly transferring ions with a nanoscale capillary. 2️⃣ GAMSI for Single-Cell Profiling: Using hydrogels to improve spatial resolution in MSI imaging. 3️⃣ 3D-Printed Mass Filters: Miniature, cost-effective QMFs are revolutionizing portability in MS. #MassSpectrometry #Innovation #Nanotech #MSI #Proteomics #3DPrinting #Biotech

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Exciting News in Biotech Collaboration! Bio-Sourcing, a Belgian biotech, has partnered with Afrigen Biologics (Pty) Ltd Biologics, a South African biotech, to launch an innovative pilot program in South Africa called BioMilk. This groundbreaking biotherapeutic platform aims to improve access to essential biotherapeutics, including monoclonal antibodies (mAbs) and insulin products. How can other countries leverage similar collaborative models to enhance their healthcare systems and ensure equitable access to vital medicines? Looking forward to your thoughts and discussions on this exciting development! #Biotech #Collaboration #HealthcareInnovation #BioMilk #BioSourcing #AfrigenBiologics #AffordableMedicine #GlobalHealth

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𝐁𝐞𝐬𝐭 𝐩𝐥𝐚𝐜𝐞𝐬 𝐭𝐨 𝐰𝐨𝐫𝐤 𝐢𝐧 𝐁𝐢𝐨𝐏𝐡𝐚𝐫𝐦𝐚 𝟐𝟎𝟐𝟓 - 𝐭𝐡𝐞 𝐫𝐞𝐬𝐮𝐥𝐭𝐬 𝐚𝐫𝐞 𝐢𝐧! 🎖️ Biospace has released its 2025 best places to work in the Biopharmaceutical sector—but this is only taken from circa 3600 employees, which is a tiny proportion of the market. 𝐃𝐨 𝐲𝐨𝐮 𝐭𝐡𝐢𝐧𝐤 𝐭𝐡𝐢𝐬 𝐠𝐢𝐯𝐞𝐬 𝐚 𝐟𝐚𝐢𝐫 𝐫𝐞𝐬𝐮𝐥𝐭? A summary of the article is attached in the comments: "BioSpace's 2025 Best Places to Work" lists 50 biopharma companies, with Moderna and Sutro Biopharma as top large and small employers. Chosen by 3,600+ life sciences pros, these companies excel in culture, growth, and innovation. Moderna prioritises belonging and continuous learning, while Sutro focuses on mission-driven work and collaboration. This recognition highlights workplaces that foster positive employee experiences and purpose-driven work. #BioPharma #BioTech #BestPlacesToWork #MasonHarding

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🧬📉 Over the last 8+ years, I have seen countless biotech and MedTech's crumble and fall victim to some OBVIOUS risks... But just because they're obvious, definitely doesn't mean they're easy to avoid. Last week I made a post about some of the obvious risks small biotech face in ANZ. I've had a couple of conversations recently with executives about some of the other risks attached to growing a small biotech. I thought it would be useful to share a few of the further things that came up: 1️⃣ 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐑𝐢𝐬𝐤: A small start-up with one asset is much more vulnerable to failure. If a clinical trial misses its endpoint, the entire company could (and will likely) collapse. Small biotech seldom has the luxury of a cash reserve... 2️⃣ 𝐅𝐢𝐧𝐚𝐧𝐜𝐢𝐚𝐥 𝐑𝐢𝐬𝐤: Developing biotech products costs MILLIONS. 💲 That's millions before they even think about generating revenue. Life science companies require multiple rounds of raising capital, just to progress through their lifecycle. Often before there is even strong data to indicate success 📉 External influences can play a huge part on raising capital. (take early 2023 through to now for examples...) Economic shifts pose risks that are beyond the company's control. 3️⃣ 𝐂𝐨𝐧𝐭𝐫𝐚𝐜𝐭𝐮𝐚𝐥 𝐑𝐢𝐬𝐤: Life sciences companies often operate with a "virtual" business model. ✍ This means outsourcing many key skills and functions While this is efficient, poorly managed contracts can create serious problems. Delays in projects, audit failures, IP ownership disputes, and unexpected liabilities can arise if contracts are not carefully drafted and managed. 🔒 Strong legal oversight is essential to protect your interests and avoid costly setbacks. 4️⃣ 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐑𝐢𝐬𝐤: Navigating regulatory compliance and approval is arguably the toughest element of biotech. Without it, a product can’t be sold. ❌ The approval process is long, complex, and highly regulated, with different rules in every country. Even after approval, unforeseen issues like adverse effects or manufacturing defects can result in product recalls, lawsuits, or a suspension of approval. All of this = 💲💲💲 5️⃣ 𝐂𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐨𝐧 𝐑𝐢𝐬𝐤: Biotech is a fiercely competitive market to operate in. Innovation is essential, but being first to market isn’t always enough. A product could be overtaken by a more effective or safer alternative from a competitor. Additionally, the product needs to outperform existing treatments otherwise it will struggle to gain traction with healthcare providers and patients. ⁉ Have I missed anything else?

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🌟 Breaking News: Touchlight, CGT Catapult, and Complement Therapeutics Join Forces! 🌟 🚀 Innovative Manufacturing Process for Gene Therapies 🚀 I'm excited to share some groundbreaking news in the biotech industry. Touchlight, Cell and Gene Therapy Catapult (CGT Catapult), and Complement Therapeutics have partnered to develop an advanced manufacturing process for gene therapies. This collaboration has been awarded over £1 million by Innovate UK and aims to revolutionise the production of recombinant adeno-associated virus (rAAV) gene therapies. 📅 Key Highlights: Grant Award: Over £1 million from Innovate UK Objective: Develop innovative rAAV production process using dbDNA™ Collaborators: Touchlight, CGT Catapult, and Complement Therapeutics 🔬 Project Details: Touchlight's enzyme-based DNA manufacturing platform will produce doggybone DNA (dbDNA™), which is significantly faster to produce than traditional plasmid DNA. This innovation aims to increase yield, lower costs, and reduce the environmental impact of manufacturing gene therapies. The dbDNA will be used to produce rAAV, which will then be utilized to manufacture Complement Therapeutics' gene therapy candidates. CGT Catapult will optimize its rAAV manufacturing and analytical platform to support this process, ultimately helping gene therapy developers across the UK. 🗣️ Statements from Leaders: Karen Fallen, CEO, Touchlight: "We are excited to combine our dbDNA technology with those of Complement Therapeutics and CGT Catapult to develop an innovative solution to AAV production. dbDNA has the potential to improve the productivity and thus, the cost of AAV manufacture, while also eliminating bacterial impurities." Rafiq Hasan, CEO, Complement Therapeutics: "We are looking forward to this collaboration in exploring the potential of this innovative dbDNA technology in the manufacture of our AAV gene therapy candidates." Matthew Durdy, CEO, CGT Catapult: "Building on Touchlight’s pioneering dbDNA platform and Complement Therapeutics’ expertise in gene therapies, we hope to develop an innovative process that streamlines viral vector manufacturing and helps to reduce the cost of advanced therapies." 🌍 Impact: This collaboration has the potential to make life-changing gene therapies more affordable and accessible by improving manufacturing processes, increasing yield, and lowering costs. #GeneTherapy #Biotechnology #InnovateUK #Touchlight #CGTCatapult #ComplementTherapeutics #dbDNA #rAAV #HealthcareInnovation #AdvancedTherapies #Biotech #MedicalResearch #LifeSciences

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Abzena 𝗘𝘅𝗽𝗮𝗻𝗱𝘀 𝗚𝗠𝗣 𝗖𝗲𝗹𝗹-𝗕𝗮𝘀𝗲𝗱 𝗣𝗼𝘁𝗲𝗻𝗰𝘆 𝗔𝘀𝘀𝗮𝘆𝘀 𝗔𝗰𝗿𝗼𝘀𝘀 𝗨𝗞 𝗮𝗻𝗱 𝗨𝗦 𝗙𝗮𝗰𝗶𝗹𝗶𝘁𝗶𝗲𝘀 Abzena has expanded its analytical services by introducing GMP cell-based potency assays at its development and manufacturing facilities in Cambridge, UK, and San Diego, CA. This expansion aims to streamline the bioassay process for clients, offering a more efficient and cost-effective way to obtain critical data. The new GMP cell-based potency assays will enable Abzena to provide precise, reliable data on the biological activity of biopharmaceuticals, including antibody-drug conjugates (ADCs). These assays are essential for both GMP product release and stability testing, helping to assess cytotoxicity and the potency of drug payloads. With this addition, Abzena strengthens its bioanalytical capabilities, which also include mechanism of action (MOA) and immunogenicity assessments for regulatory submissions. #CDMO #ContractDevelopment #ContractManufacturing

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Current Advancements in TPD Therapeutics in the UK 🇬🇧 The field of Targeted Protein Degradation (TPD) is gaining significant traction in the UK. TPD, which utilises the body’s natural protein degradation mechanisms to eliminate disease-causing proteins, is set to transform treatment approaches for a range of conditions including cancer and neurodegenerative diseases. Key Highlights: Biotech Leaders: The UK is emerging as a global leader in TPD, with numerous spin-outs and biotech start-ups focused on developing novel protein degraders. Companies such as C4X Discovery, Mission Therapeutics, and Exscientia are at the forefront, advancing both the science and its application in drug discovery. Investment Growth: Significant funding rounds have been secured by UK-based TPD-focused companies, reflecting investor confidence in the potential of these technologies. This influx of capital is accelerating research and development, leading to swift advancements and a robust pipeline of TPD-based therapeutics. Growing Collaborations: The UK’s collaborative environment between academia, industry, and government is fostering innovation in TPD. Strategic partnerships with large pharma and research institutions are enabling biotech companies to scale their efforts and bring therapies to market more efficiently. Regulatory Support: The UK’s regulatory framework is evolving to accommodate the unique challenges of TPD therapeutics, offering a supportive environment for clinical trials and the commercialisation of new treatments. What are your thoughts on the future impact of TPD on the biotech industry? #Biotech #TargetedProteinDegradation #DrugDiscovery #UKBiotech #TPD #Innovation #Healthcare

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